Locally Advanced Cervical CarcinomaPhase 2NCT04789941
How To Evaluate The Efficiency And Safety Of Neoadjuvant Chemotherapy In Locally Advanced Cancer Cervix
A Phase 2 study testing Cis Platinum + Irinotecan in people with Locally Advanced Cervical Carcinoma, run by Assiut University.
Trial summary
1. This strategy might suggest a therapeutic option to preserve ovarian function in young patients among which locally advanced cancer cervix is common. Based on previous studies, neoadjuvant irinotecan and cisplatin followed by radical hysterectomy and adjuvant chemotherapy has the potential to improve the prognosis… Read more about this study
- Who is it for?
- Ages 20 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Locally Advanced Cervical Carcinoma
- What is being tested?
- Cis Platinum + Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 30 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1 - Patients with histologically confirmed invasive squamous cell carcinoma of the uterine cervix; (ii) FIGO stage system (2018 version): stage II-III 2- No previous treatment. 3- patients with age of 20-75 years at enrollment. 4- Eastern Cooperative Oncology Group performance status (PS) of 0 or 1. 5- Preserved function of major organs (bone marrow, heart, liver and kidney) 6- Lab values within specified ranges, including a neutrophil count greater than 2000/μL, a platelet count greater than 100 000/ mm3 , a hemoglobin level greater than 9.0 g/dL (values after blood transfusion are accepted), levels of aspartate aminotransferase and alanine aminotransferase less than 100 IU/L, a total bilirubin level less than 1.5 mg/dL, a serum creatinine level less than 1.5 mg/dL, creatinine clearance greater than 60 mL/ min.
Who cannot join
- Distinct evidence of infectious disease.
- Serious concurrent disease (cardiac disease, uncontrolled diabetes mellitus, malignant hypertension and a bleeding tendency).
- Pregnant women, or women who want to become pregnant.
- History of serious drug hypersensitivity or drug allergy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase II Trial To Evaluate The Efficiency And Safety Of Neoadjuvant Chemotherapy In Locally Advanced Cancer Cervix
- This strategy might suggest a therapeutic option to preserve ovarian function in young patients among which locally advanced cancer cervix is common. Based on previous studies, neoadjuvant irinotecan and cisplatin followed by radical hysterectomy and adjuvant chemotherapy has the potential to improve the prognosis compared the concurrent chemo-radiotherapy(CCRT).
- To offer an alternative effective treatment line replacing concurrent chemo-radiotherapy to avoid dramatic radiotherapy induced complications which might impede a safe successful surgery.
2- To reduce the proportion of patients who will go for radiotherapy, consequently those patients will still have a chance of probable less complicated surgery in case of local recurrence.
Read more
3- This study will involve neo-adjuvant chemotherapy (NACT) in treating patients with stage II-III cervical cancer for reducing tumor size, minimizing blood loss during surgery and eradication of possible micro-metastasis.
4- To Improve the likelihood of achieving complete tumor resection after NACT. 5- Investigators will further follow-up those patients for more detailed assessments to confirm whether NACT can improve patients' prognoses, survival, quality of life, and the standard of care.
Read the detailed description
Treatments for locally advanced cervical cancer, defined as International Federation of Gynecology and Obstetrics (FIGO) stage Ib2-III include primary surgery, neoadjuvant chemotherapy and concurrent chemo-radiotherapy (CCRT). In many countries, CCRT is accepted as the standard therapy for such tumors. However, each of these therapies has both advantages and disadvantages, however, more recently it has been given using neoadjuvant chemotherapy with intravenous irinotecan hydrochloride (CPT-11) and cisplatin. DNA topoisomerases are enzymes that regulate and control DNA topology. Topoisomerase 1 catalyzes the transient cutting of a single DNA strand, the passage of another DNA strand through the break and then resealing of the DNA break. Camptothecin (CPT), an antitumor alkaloid isolated from Camptotheca acuminata, interferes with DNA topoisomerase 1 function. Cisplatin (cis-dichlorodiammineplatinums II) is a first generation platinum compound. Platinum-based NACT followed by radical hysterectomy has been proposed as an alternative approach to radiotherapy or CCRT in locally advanced cervical cancer, especially of squamous cell histology, with objective response rates ranging from 69.4% to 90.2%, pathological optimal response rates ranging from 21.3% to 48.3%, 5-year disease free survival (DFS) rates ranging from 55.4% to 71% and 5-year overall survival(OS) rates ranging from 58.9% to 81%, respectively.
- Conditions
- Locally Advanced Cervical Carcinoma
- Being tested
- Cis Platinum + Irinotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cis Platinum + IrinotecanDrug
Also called No other interventions, investigators are trying only one intervention to test if it could be an alternative effective line for treating the patients with locally advanced cancer cervix.
Studying the efficacy and safety of neoadjuvant cisplatin and irinotecan use in treatment of locally advanced cancer cervix.
| Study group | Role | What they receive |
|---|---|---|
| Single arm of patients with locally advanced cancer cervix | Experimental | Single arm study to assess the efficacy and safety of use of neoadjuvant cisplatin and irinotecan in treatment of patients with locally advanced cancer cervix.
A combined regimen of intravenous infusion of cisplatin 80mg/m2 on day 1 with irinotecan 60mg/m2 on day 1 and day 8 of every 21- day cycle for 3 cycles.
Then, MRI pelvis will be used for assessment of disease response. According to RECIST criteria, patients who will develop at least stable disease, will be sent for radical hysterectomy. Afterwards, 6 weeks after the surgery, another 3 cycles of the same regimen will be given to the participants as adjuvant treatment. Receives: Drug: Cis Platinum + Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respectability of the tumor
Evaluation of the effect of use of neoadjuvant cisplatin and irinotecan on the tumor size when assessed by MRI pelvis cancer
Evaluation of the tumor size by MRI pelvis after giving 3 cycles of cisplatin and irinotecan. So, baseline( prechemotherapy) MRI pelvis and another re-evaluation MRI pelvis will be used for proper assessment.
Measured: Evaluation will be done by MRI pelvis after 3 cycles( of the 21- day cycle) of chemotherapy
Secondary outcomes (3)
2- year relapse free survival(RFS)
Evaluation of the effect of use of neoadjuvant cisplatin and irinotecan on the 2- year RFS of patients with locally advanced cancer cervix
Measured: 2 years
2- year overall survival(OS)
Evaluation of the effect of use of neoadjuvant cisplatin and irinotecan on the 2- year OS of patients with locally advanced cancer cervix
Measured: 2 years
Toxicity profile
Investigators will assess the incidence of treatment related adverse events ( e.g neutropenia,mucositis,renal insufficiency, neuropathy, nausea and vomiting)and its severity on the CTCAE scale of 5 grades ( mild,moderate,severe,life- threatening, and death related to AE. )
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MAI MOHAMED HEMMAT ABDELFATAH ABDELGELIL, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789941
- Sponsor's protocol ID
- Treatment Of Cancer Cervix
- Status last verified
- Mar 2021
- First submitted
- 28 Nov 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prat J; FIGO Committee on Gynecologic Oncology. Staging classification for cancer of the ovary, fallopian tube, and peritoneum. Int J Gynaecol Obstet. 2014 Jan;124(1):1-5. doi: 10.1016/j.ijgo.2013.10.001. Epub 2013 Oct 22. No abstract available.
PubMed 24219974Katsumata N, Yoshikawa H, Kobayashi H, Saito T, Kuzuya K, Nakanishi T, Yasugi T, Yaegashi N, Yokota H, Kodama S, Mizunoe T, Hiura M, Kasamatsu T, Shibata T, Kamura T; Japan Clinical Oncology Group. Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102). Br J Cancer. 2013 May 28;108(10):1957-63. doi: 10.1038/bjc.2013.179. Epub 2013 May 2.
PubMed 23640393Gadducci A, Sartori E, Maggino T, Zola P, Cosio S, Zizioli V, Lapresa M, Piovano E, Landoni F. Pathological response on surgical samples is an independent prognostic variable for patients with Stage Ib2-IIb cervical cancer treated with neoadjuvant chemotherapy and radical hysterectomy: an Italian multicenter retrospective study (CTF Study). Gynecol Oncol. 2013 Dec;131(3):640-4. doi: 10.1016/j.ygyno.2013.09.029. Epub 2013 Oct 3.
PubMed 24096111Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43. doi: 10.1056/NEJM199904153401501.
PubMed 10202164Rose PG, Bundy BN, Watkins EB, Thigpen JT, Deppe G, Maiman MA, Clarke-Pearson DL, Insalaco S. Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1144-53. doi: 10.1056/NEJM199904153401502.
PubMed 10202165Green JA, Kirwan JM, Tierney JF, Symonds P, Fresco L, Collingwood M, Williams CJ. Survival and recurrence after concomitant chemotherapy and radiotherapy for cancer of the uterine cervix: a systematic review and meta-analysis. Lancet. 2001 Sep 8;358(9284):781-6. doi: 10.1016/S0140-6736(01)05965-7.
PubMed 11564482Lukka H, Hirte H, Fyles A, Thomas G, Elit L, Johnston M, Fung MF, Browman G; Cancer Care Ontario Practice Guidelines Initiative Gynecology Disease Site Group. Concurrent cisplatin-based chemotherapy plus radiotherapy for cervical cancer--a meta-analysis. Clin Oncol (R Coll Radiol). 2002 Jun;14(3):203-12. doi: 10.1053/clon.2002.0076.
PubMed 12109823Holden JA. Human deoxyribonucleic acid topoisomerases: molecular targets of anticancer drugs. Ann Clin Lab Sci. 1997 Nov-Dec;27(6):402-12.
PubMed 9433537Hsiang YH, Hertzberg R, Hecht S, Liu LF. Camptothecin induces protein-linked DNA breaks via mammalian DNA topoisomerase I. J Biol Chem. 1985 Nov 25;260(27):14873-8.
PubMed 2997227Gupta S, Maheshwari A, Parab P, Mahantshetty U, Hawaldar R, Sastri Chopra S, Kerkar R, Engineer R, Tongaonkar H, Ghosh J, Gulia S, Kumar N, Shylasree TS, Gawade R, Kembhavi Y, Gaikar M, Menon S, Thakur M, Shrivastava S, Badwe R. Neoadjuvant Chemotherapy Followed by Radical Surgery Versus Concomitant Chemotherapy and Radiotherapy in Patients With Stage IB2, IIA, or IIB Squamous Cervical Cancer: A Randomized Controlled Trial. J Clin Oncol. 2018 Jun 1;36(16):1548-1555. doi: 10.1200/JCO.2017.75.9985. Epub 2018 Feb 12.
PubMed 29432076Neoadjuvant Chemotherapy for Cervical Cancer Meta-Analysis Collaboration (NACCCMA) Collaboration. Neoadjuvant chemotherapy for locally advanced cervix cancer. Cochrane Database Syst Rev. 2004;2004(2):CD001774. doi: 10.1002/14651858.CD001774.pub2.
PubMed 15106161Wang PH, Chang YH, Yang YH, Chang WH, Huang SY, Lai CR, Juang CM, Chen YJ, Horng HC, Wen KC, Ng HT, Yuan CC, Chao KC, Yen MS. Outcome of patients with bulky IB (>/= 6 cm) cervical squamous cell carcinoma with and without cisplatin-based neoadjuvant chemotherapy. Taiwan J Obstet Gynecol. 2014 Sep;53(3):330-6. doi: 10.1016/j.tjog.2014.05.001.
PubMed 25286786Li R, Lu ST, Si JG, Liu B, Wang H, Mei YY, Linghu H. Prognostic value of responsiveness of neoadjuvant chemotherapy before surgery for patients with stage IB(2)/IIA(2) cervical cancer. Gynecol Oncol. 2013 Mar;128(3):524-9. doi: 10.1016/j.ygyno.2012.11.006. Epub 2012 Nov 9.
PubMed 23146686
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial To Evaluate The Efficiency And Safety Of Neoadjuvant Chemotherapy In Locally Advanced Cancer Cervix
- ClinicalTrials.gov ID
- NCT04789941
- Acronym / sponsor ID
- Treatment Of Cancer Cervix
- Conditions
- Locally Advanced Cervical Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- This strategy might suggest a therapeutic option to preserve ovarian function in young patients among which locally advanced cancer cervix is common. Based on previous studies, neoadjuvant irinotecan and cisplatin followed by radical hysterectomy and adjuvant chemotherapy has the potential to improve the prognosis compared the concurrent chemo-radiotherapy(CCRT).
- To offer an alternative effective treatment line replacing concurrent chemo-radiotherapy to avoid dramatic radiotherapy induced complications which might impede a safe successful surgery.
2- To reduce the proportion of patients who will go for radiotherapy, consequently those patients will still have a chance of probable less complicated surgery in case of local recurrence.
3- This study will involve neo-adjuvant chemotherapy (NACT) in treating patients with stage II-III cervical cancer for reducing tumor size, minimizing blood loss during surgery and eradication of possible micro-metastasis.
4- To Improve the likelihood of achieving complete tumor resection after NACT. 5- Investigators will further follow-up those patients for more detailed assessments to confirm whether NACT can improve patients' prognoses, survival, quality of life, and the standard of care.
Detailed description
Treatments for locally advanced cervical cancer, defined as International Federation of Gynecology and Obstetrics (FIGO) stage Ib2-III include primary surgery, neoadjuvant chemotherapy and concurrent chemo-radiotherapy (CCRT). In many countries, CCRT is accepted as the standard therapy for such tumors. However, each of these therapies has both advantages and disadvantages, however, more recently it has been given using neoadjuvant chemotherapy with intravenous irinotecan hydrochloride (CPT-11) and cisplatin. DNA topoisomerases are enzymes that regulate and control DNA topology. Topoisomerase 1 catalyzes the transient cutting of a single DNA strand, the passage of another DNA strand through the break and then resealing of the DNA break. Camptothecin (CPT), an antitumor alkaloid isolated from Camptotheca acuminata, interferes with DNA topoisomerase 1 function. Cisplatin (cis-dichlorodiammineplatinums II) is a first generation platinum compound. Platinum-based NACT followed by radical hysterectomy has been proposed as an alternative approach to radiotherapy or CCRT in locally advanced cervical cancer, especially of squamous cell histology, with objective response rates ranging from 69.4% to 90.2%, pathological optimal response rates ranging from 21.3% to 48.3%, 5-year disease free survival (DFS) rates ranging from 55.4% to 71% and 5-year overall survival(OS) rates ranging from 58.9% to 81%, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm of patients with locally advanced cancer cervix | Experimental | Drug: Cis Platinum + IrinotecanSingle arm study to assess the efficacy and safety of use of neoadjuvant cisplatin and irinotecan in treatment of patients with locally advanced cancer cervix. A combined regimen of intravenous infusion of cisplatin 80mg/m2 on day 1 with irinotecan 60mg/m2 on day 1 and day 8 of every 21- day cycle for 3 cycles. Then, MRI pelvis will be used for assessment of disease response. According to RECIST criteria, patients who will develop at least stable disease, will be sent for radical hysterectomy. Afterwards, 6 weeks after the surgery, another 3 cycles of the same regimen will be given to the participants as adjuvant treatment. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1 - Patients with histologically confirmed invasive squamous cell carcinoma of the uterine cervix; (ii) FIGO stage system (2018 version): stage II-III 2- No previous treatment. 3- patients with age of 20-75 years at enrollment. 4- Eastern Cooperative Oncology Group performance status (PS) of 0 or 1. 5- Preserved function of major organs (bone marrow, heart, liver and kidney) 6- Lab values within specified ranges, including a neutrophil count greater than 2000/μL, a platelet count greater than 100 000/ mm3 , a hemoglobin level greater than 9.0 g/dL (values after blood transfusion are accepted), levels of aspartate aminotransferase and alanine aminotransferase less than 100 IU/L, a total bilirubin level less than 1.5 mg/dL, a serum creatinine level less than 1.5 mg/dL, creatinine clearance greater than 60 mL/ min.
Key exclusion criteria (4 listed)
- Distinct evidence of infectious disease.
- Serious concurrent disease (cardiac disease, uncontrolled diabetes mellitus, malignant hypertension and a bleeding tendency).
- Pregnant women, or women who want to become pregnant.
- History of serious drug hypersensitivity or drug allergy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cis Platinum + IrinotecanAlso: No other interventions, investigators are trying only one intervention to test if it could be an alternative effective line for treating the patients with locally advanced cancer cervix.Studying the efficacy and safety of neoadjuvant cisplatin and irinotecan use in treatment of locally advanced cancer cervix. | Drug | Single arm of patients with locally advanced cancer cervix |
Primary outcome
Respectability of the tumor
Time frame: Evaluation will be done by MRI pelvis after 3 cycles( of the 21- day cycle) of chemotherapy
Evaluation of the effect of use of neoadjuvant cisplatin and irinotecan on the tumor size when assessed by MRI pelvis cancer Evaluation of the tumor size by MRI pelvis after giving 3 cycles of cisplatin and irinotecan. So, baseline( prechemotherapy) MRI pelvis and another re-evaluation MRI pelvis will be used for proper assessment.
3 secondary outcomes
2- year relapse free survival(RFS)
Time frame: 2 years
2- year overall survival(OS)
Time frame: 2 years
Toxicity profile
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Background: PubMed 24219974Prat J; FIGO Committee on Gynecologic Oncology. Staging classification for cancer of the ovary, fallopian tube, and peritoneum. Int J Gynaecol Obstet. 2014 Jan;124(1):1-5. doi: 10.1016/j.ijgo.2013.10.001. Epub 2013 Oct 22. No abstract available.
- Background: PubMed 23640393Katsumata N, Yoshikawa H, Kobayashi H, Saito T, Kuzuya K, Nakanishi T, Yasugi T, Yaegashi N, Yokota H, Kodama S, Mizunoe T, Hiura M, Kasamatsu T, Shibata T, Kamura T; Japan Clinical Oncology Group. Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102). Br J Cancer. 2013 May 28;108(10):1957-63. doi: 10.1038/bjc.2013.179. Epub 2013 May 2.
- Background: PubMed 24096111Gadducci A, Sartori E, Maggino T, Zola P, Cosio S, Zizioli V, Lapresa M, Piovano E, Landoni F. Pathological response on surgical samples is an independent prognostic variable for patients with Stage Ib2-IIb cervical cancer treated with neoadjuvant chemotherapy and radical hysterectomy: an Italian multicenter retrospective study (CTF Study). Gynecol Oncol. 2013 Dec;131(3):640-4. doi: 10.1016/j.ygyno.2013.09.029. Epub 2013 Oct 3.
- Background: PubMed 10202164Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43. doi: 10.1056/NEJM199904153401501.
- Background: PubMed 10202165Rose PG, Bundy BN, Watkins EB, Thigpen JT, Deppe G, Maiman MA, Clarke-Pearson DL, Insalaco S. Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1144-53. doi: 10.1056/NEJM199904153401502.
- Background: PubMed 11564482Green JA, Kirwan JM, Tierney JF, Symonds P, Fresco L, Collingwood M, Williams CJ. Survival and recurrence after concomitant chemotherapy and radiotherapy for cancer of the uterine cervix: a systematic review and meta-analysis. Lancet. 2001 Sep 8;358(9284):781-6. doi: 10.1016/S0140-6736(01)05965-7.
- Background: PubMed 12109823Lukka H, Hirte H, Fyles A, Thomas G, Elit L, Johnston M, Fung MF, Browman G; Cancer Care Ontario Practice Guidelines Initiative Gynecology Disease Site Group. Concurrent cisplatin-based chemotherapy plus radiotherapy for cervical cancer--a meta-analysis. Clin Oncol (R Coll Radiol). 2002 Jun;14(3):203-12. doi: 10.1053/clon.2002.0076.
- Background: PubMed 9433537Holden JA. Human deoxyribonucleic acid topoisomerases: molecular targets of anticancer drugs. Ann Clin Lab Sci. 1997 Nov-Dec;27(6):402-12.
- Background: PubMed 2997227Hsiang YH, Hertzberg R, Hecht S, Liu LF. Camptothecin induces protein-linked DNA breaks via mammalian DNA topoisomerase I. J Biol Chem. 1985 Nov 25;260(27):14873-8.
- Background: PubMed 29432076Gupta S, Maheshwari A, Parab P, Mahantshetty U, Hawaldar R, Sastri Chopra S, Kerkar R, Engineer R, Tongaonkar H, Ghosh J, Gulia S, Kumar N, Shylasree TS, Gawade R, Kembhavi Y, Gaikar M, Menon S, Thakur M, Shrivastava S, Badwe R. Neoadjuvant Chemotherapy Followed by Radical Surgery Versus Concomitant Chemotherapy and Radiotherapy in Patients With Stage IB2, IIA, or IIB Squamous Cervical Cancer: A Randomized Controlled Trial. J Clin Oncol. 2018 Jun 1;36(16):1548-1555. doi: 10.1200/JCO.2017.75.9985. Epub 2018 Feb 12.
- Background: PubMed 15106161Neoadjuvant Chemotherapy for Cervical Cancer Meta-Analysis Collaboration (NACCCMA) Collaboration. Neoadjuvant chemotherapy for locally advanced cervix cancer. Cochrane Database Syst Rev. 2004;2004(2):CD001774. doi: 10.1002/14651858.CD001774.pub2.
- Background: PubMed 25286786Wang PH, Chang YH, Yang YH, Chang WH, Huang SY, Lai CR, Juang CM, Chen YJ, Horng HC, Wen KC, Ng HT, Yuan CC, Chao KC, Yen MS. Outcome of patients with bulky IB (>/= 6 cm) cervical squamous cell carcinoma with and without cisplatin-based neoadjuvant chemotherapy. Taiwan J Obstet Gynecol. 2014 Sep;53(3):330-6. doi: 10.1016/j.tjog.2014.05.001.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cis Platinum + Irinotecan in people with Locally Advanced Cervical Carcinoma, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mai ABDELGELIL, Oncologist (00201026556852, maihemmat86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respectability of the tumor (time frame: Evaluation will be done by MRI pelvis after 3 cycles( of the 21- day cycle) of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04789941, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.