Cancer, RectumPhase 3STELLARNCT02533271
Optimization of Preoperative Treatment in Locally Advanced Rectal Cancer
A Phase 3 study testing Short-course radiotherapy with neoadjuvant chemotherapy and Long-term chemoradiotherapy in people with Cancer, Rectum, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to compare effectiveness of short-term radiotherapy with neoadjuvant chemotherapy(TNT group) with preoperative long-term chemoradiotherapy(CRT group) in locally advanced rectal cancer. The hypothesis is 3-year disease-free survival in TNT group was non-inferior to that in CRT group. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer, Rectum
- What is being tested?
- Short-course radiotherapy with neoadjuvant chemotherapy and Long-term chemoradiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Aug 2025
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven rectal adenocarcinoma;
- Distance between tumour and anal verge≤ 10cm;
- Locally advanced tumour;(AJCC Cancer Staging:T3, T4 or N+)
- Cancer Staging must be based on pelvic MRI;
- Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;
- Written informed consent;
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- Mentally and physically fit for chemotherapy;
- Adequate blood counts: White blood cell count ≥3.5 x 109/L Haemoglobin levels ≥100g/L Platelet count ≥100 x 109/L Creatinine levels ≤1.0× upper normal limit（UNL） Urea nitrogen levels ≤1.0× upper normal limit（UNL） Alanine aminotransferase(ALT) ≤1.5× upper normal limit（UNL） Aspartate aminotransferase(AST) ≤1.5× upper normal limit（UNL） Alkaline phosphatase(ALP) ≤1.5× upper normal limit（UNL） Total bilirubin(TBIL) ≤1.5× upper normal limit（UNL）
- No excision of tumor, chemotherapy or other anti-tumor treatment after the diagnosis.
Who cannot join
- Distant metastases;
- Recurrent rectal cancer;
- Active Crohn's disease or ulcerative colitis;
- Concomitant malignancies;(except basocellular carcinoma or in-situ cervical carcinoma)
- Allergic to Fluorouracil or Platinum drugs;
- Contraindications to MRI for any reason;
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- Concurrent uncontrolled medical condition;
- Pregnancy or breast feeding;
- Known malabsorption syndromes or lack of physical integrity of upper gastrointestinal tract;
- Symptoms or history of peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Beijing, Beijing Municipality
Yang Tang, +86-15011304945, tangyuan82@126.com
Jing Jin, +86-13601365130, jingjin1025@163.com
About this study
Official title: Phase III Study of Short-term Radiotherapy Plus Neoadjuvant Chemotherapy Versus Preoperative Long-term Chemoradiotherapy in Locally Advanced Rectal Cancer
The purpose of this study is to compare effectiveness of short-term radiotherapy with neoadjuvant chemotherapy(TNT group) with preoperative long-term chemoradiotherapy(CRT group) in locally advanced rectal cancer. The hypothesis is 3-year disease-free survival in TNT group was non-inferior to that in CRT group.
Read the detailed description
The study is a prospective phase III randomized multicenter trial. The purpose of this study is to compare short-term radiotherapy with neoadjuvant chemotherapy(TNT group) with preoperative long-term chemoradiotherapy(CRT group) for middle-lower locally advanced rectal cancer. The primary endpoint is 3-year disease-free survival,defined as the interval from randomization to the first occurrence of local-regional failure, distant metastasis, second primary tumor or death from any cause. The primary hypothesis was that DFS in the TNT group would be non-inferior to that in the CRT group. After preoperative radiotherapy and surgery, the DFS rate of LARC fluctuated from 50% to 65%. Assuming a 3-year DFS rate in CRT group is 65%, we consider the 3-year DFS rate in the TNT group is not lower than 54% (e.g., a margin of 11% or equivalently, hazard ratio (HR) < 1.43). Guarding against a 5% ineligibility or drop-out rate, the accrual target was 600 patients, with the final analysis to occur after at least 194 DFS events to provide at least 80% power at 1-sided type 1 error of 0.05. The choices of type 1 error and power were made to provide an appropriate comprise between feasibility, timeliness and statistical rigor of evidence generation.
This study seeks to compare outcomes between two groups with respect to rates of overall survival(OS), distance metastasis free survival (DMFS), and locoregional recurrence free survival (LRRFS).In addition, acute and late toxicity profile, completion of preoperative treatment, the proportion of patients with radical resection (R0), surgical complication profile, the rate of pathological complete response (pCR), and quality of life (QoL) are also secondary endpoints.
The STELLAR-trial has been designed by National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, and the hypothesis is 3-year disease-free survival in TNT group was non-inferior to that in CRT group.
- Conditions
- Cancer, Rectum
- Being tested
- Short-course radiotherapy with neoadjuvant chemotherapy, Long-term chemoradiotherapy
- Keywords
- rectal cancer, short-term radiotherapy, neoadjuvant chemotherapy, total mesorectal excision
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-course radiotherapy with neoadjuvant chemotherapyRadiation
Short-course radiotherapy with 4 cycles of neoadjuvant chemotherapy
Long-term chemoradiotherapyRadiation
Standard chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| TNT group | Experimental | The intervention of TNT group is Short-course radiotherapy with neoadjuvant chemotherapy, which consists of a short-course radiotherapy (SCRT, 5 Gy x 5 alone), then after 7-10 days of radiotherapy completed, patients will receive neoadjuvant chemotherapy, given in 3 week cycle of capecitabine 1000 mg/m2 twice daily, day 1-14 combined with oxaliplatin 130 mg/m2 once. In total, 4 cycles of neoadjuvant chemotherapy are prescribed preoperatively, then followed by a total mesorectal excision(TME) and postoperative adjuvant chemotherapy. If patients are eligible for postoperative chemotherapy this should consist of at least 2 cycles, which are the same as neoadjuvant chemotherapy. Receives: Radiation: Short-course radiotherapy with neoadjuvant chemotherapy |
| CRT group | Other | The intervention of CRT group is long-term chemoradiotherapy(CRT), which consists of a long-term chemoradiation (2 Gy x 25 with capecitabine) preoperatively, followed by a total mesorectal excision(TME) and then postoperative adjuvant chemotherapy. The radiotherapy is given in combination with capecitabine in a dose of 825 mg/m2 twice daily on days when radiotherapy, excluding weekends. If patients are eligible for postoperative chemotherapy this should consist of at least 6 cycles of capecitabine 1000 mg/m2 twice daily, day 1-14 combined with oxaliplatin 130 mg/m2 once every 3 weeks. Receives: Radiation: Long-term chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival rate
Measured: three year
Secondary outcomes (8)
Overall survival rate
Measured: three year
Distance metastasis free survival rate
Measured: three year
Locoregional recurrence free survival rate
Measured: three year
Incidence of surgical complications
Surgical complications are defined as those occurring within 30 days after surgery, such as re-operation, anastomotic fistula, bleeding, infection and death related to the operation, etc.
Measured: one month
Incidence of acute toxicities during radiation or chemotherapy
Number of participants with abnormal laboratory values and/or adverse events that are related to radiation or chemotherapy as assessed by Common Toxicity Criteria for Adverse Effects(CTCAE) v4.0.
Measured: three months
Radical resection (R0)
R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after neoadjuvant therapy
Measured: one year
The rate of pathological complete response (pCR)
PCR rate is pathological ypT0N0 probability of radical surgery in patients with locally advanced rectal cancer after neoadjuvant therapy
Measured: one year
Quality of life (QoL)
Quality of life will be assessed using the EORTC QLQ C30, EORTC QLQ Cr29 and Wexner score.
Measured: up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2023 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cancer, RectumStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Jin, M.D., Chinese Academy of Medical Sciences
- Investigators
- Jing Jin, Study director, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533271
- Sponsor's protocol ID
- XT2015-03
- Other IDs
- CH-GI-090
- Acronym
- STELLAR
- Status last verified
- Jul 2021
- First submitted
- 21 Aug 2015
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tang Y, Zhou HT, Xu TZ, Li N, Jiang LM, Jiang J, Lu NN, Li S, Chen SL, Ma HY, Cai Y, Li YH, Zhu Y, He MY, Wang X, Liu K, Zhang HY, Wang J, Zhao T, Li GF, Yang JL, Zhang K, Wang WL, Xiao WW, Chi Y, Yang L, Zhou AP, Zou SM, Fang H, Wang SL, Zhang HZ, Wang XS, Wei LC, Liu SX, Gao YH, Li YX, Hu C, Jin J. Five-Year Outcomes of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy for Locally Advanced Rectal Cancer: Updated Results of the STELLAR Trial. J Clin Oncol. 2026 Sep;44(25):2371-2378. doi: 10.1200/JCO-25-02387. Epub 2026 Jul 27.
PubMed 42507974Wang N, Xu T, Li H, Shuai J, Ma H, Fang H, Song Y, Chen B, Lu N, Jing H, Liu X, Qi S, Zhang W, Liu Y, Li Y, Wang S, Dou L, Jin J, Tang Y. Diabetes and Performance Status Predict Severe, Persistent Radiation Proctitis: Long-Term Endoscopic Findings From STELLAR Trial. Int J Radiat Oncol Biol Phys. 2026 May 15:S0360-3016(26)00722-4. doi: 10.1016/j.ijrobp.2026.05.004. Online ahead of print.
PubMed 42142768Xu T, Ma H, Zhang W, Yang Y, Xiao W, Li N, Li H, Gao Y, Liu S, Wei L, Jiang L, Shi J, Shuai J, Cai Y, Li Y, Cheng G, Luo W, Wang X, Liu K, Wang J, Lu N, Fang H, Liu Y, Song Y, Zhang W, Wang S, Li Y, Zhou A, Zhou H, Chi Y, Tang Y, Jin J. Minimum 18-week chemotherapy improves survival in locally advanced rectal cancer after neoadjuvant radiotherapy: a post hoc analysis of the STELLAR trial. BMC Med. 2026 Feb 25;24(1):190. doi: 10.1186/s12916-026-04731-0.
PubMed 41742206Ma H, Li H, Xu T, Gao Y, Liu S, Wang W, Wei L, Wang X, Jiang L, Chi Y, Shi J, Shuai J, Zou S, Cai Y, Zhu Y, Cheng G, Zhang H, Wang X, Zhu S, Wang J, Li G, Yang J, Zhang K, Lu N, Fang H, Wang S, Li Y, Zhou H, Tang Y, Jin J. Multidisciplinary team quality improves the survival outcomes of locally advanced rectal cancer patients: A post hoc analysis of the STELLAR trial. Radiother Oncol. 2024 Nov;200:110524. doi: 10.1016/j.radonc.2024.110524. Epub 2024 Sep 5.
PubMed 39243864Jin J, Tang Y, Hu C, Jiang LM, Jiang J, Li N, Liu WY, Chen SL, Li S, Lu NN, Cai Y, Li YH, Zhu Y, Cheng GH, Zhang HY, Wang X, Zhu SY, Wang J, Li GF, Yang JL, Zhang K, Chi Y, Yang L, Zhou HT, Zhou AP, Zou SM, Fang H, Wang SL, Zhang HZ, Wang XS, Wei LC, Wang WL, Liu SX, Gao YH, Li YX. Multicenter, Randomized, Phase III Trial of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy in Locally Advanced Rectal Cancer (STELLAR). J Clin Oncol. 2022 May 20;40(15):1681-1692. doi: 10.1200/JCO.21.01667. Epub 2022 Mar 9.
PubMed 35263150
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Short-term Radiotherapy Plus Neoadjuvant Chemotherapy Versus Preoperative Long-term Chemoradiotherapy in Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT02533271
- Acronym / sponsor ID
- STELLAR / XT2015-03
- Conditions
- Cancer, Rectum
- Keywords
- rectal cancer, short-term radiotherapy, neoadjuvant chemotherapy, total mesorectal excision
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 26 Aug 2015 (estimated)
- 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.
The purpose of this study is to compare effectiveness of short-term radiotherapy with neoadjuvant chemotherapy(TNT group) with preoperative long-term chemoradiotherapy(CRT group) in locally advanced rectal cancer. The hypothesis is 3-year disease-free survival in TNT group was non-inferior to that in CRT group.
Detailed description
The study is a prospective phase III randomized multicenter trial. The purpose of this study is to compare short-term radiotherapy with neoadjuvant chemotherapy(TNT group) with preoperative long-term chemoradiotherapy(CRT group) for middle-lower locally advanced rectal cancer. The primary endpoint is 3-year disease-free survival,defined as the interval from randomization to the first occurrence of local-regional failure, distant metastasis, second primary tumor or death from any cause. The primary hypothesis was that DFS in the TNT group would be non-inferior to that in the CRT group. After preoperative radiotherapy and surgery, the DFS rate of LARC fluctuated from 50% to 65%. Assuming a 3-year DFS rate in CRT group is 65%, we consider the 3-year DFS rate in the TNT group is not lower than 54% (e.g., a margin of 11% or equivalently, hazard ratio (HR) < 1.43). Guarding against a 5% ineligibility or drop-out rate, the accrual target was 600 patients, with the final analysis to occur after at least 194 DFS events to provide at least 80% power at 1-sided type 1 error of 0.05. The choices of type 1 error and power were made to provide an appropriate comprise between feasibility, timeliness and statistical rigor of evidence generation.
This study seeks to compare outcomes between two groups with respect to rates of overall survival(OS), distance metastasis free survival (DMFS), and locoregional recurrence free survival (LRRFS).In addition, acute and late toxicity profile, completion of preoperative treatment, the proportion of patients with radical resection (R0), surgical complication profile, the rate of pathological complete response (pCR), and quality of life (QoL) are also secondary endpoints.
The STELLAR-trial has been designed by National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, and the hypothesis is 3-year disease-free survival in TNT group was non-inferior to that in CRT group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNT group | Experimental | Radiation: Short-course radiotherapy with neoadjuvant chemotherapyThe intervention of TNT group is Short-course radiotherapy with neoadjuvant chemotherapy, which consists of a short-course radiotherapy (SCRT, 5 Gy x 5 alone), then after 7-10 days of radiotherapy completed, patients will receive neoadjuvant chemotherapy, given in 3 week cycle of capecitabine 1000 mg/m2 twice daily, day 1-14 combined with oxaliplatin 130 mg/m2 once. In total, 4 cycles of neoadjuvant chemotherapy are prescribed preoperatively, then followed by a total mesorectal excision(TME) and postoperative adjuvant chemotherapy. If patients are eligible for postoperative chemotherapy this should consist of at least 2 cycles, which are the same as neoadjuvant chemotherapy. |
| CRT group | Other | Radiation: Long-term chemoradiotherapyThe intervention of CRT group is long-term chemoradiotherapy(CRT), which consists of a long-term chemoradiation (2 Gy x 25 with capecitabine) preoperatively, followed by a total mesorectal excision(TME) and then postoperative adjuvant chemotherapy. The radiotherapy is given in combination with capecitabine in a dose of 825 mg/m2 twice daily on days when radiotherapy, excluding weekends. If patients are eligible for postoperative chemotherapy this should consist of at least 6 cycles of capecitabine 1000 mg/m2 twice daily, day 1-14 combined with oxaliplatin 130 mg/m2 once every 3 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Biopsy proven rectal adenocarcinoma;
- Distance between tumour and anal verge≤ 10cm;
- Locally advanced tumour;(AJCC Cancer Staging:T3, T4 or N+)
- Cancer Staging must be based on pelvic MRI;
- Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;
Key exclusion criteria (10 listed)
- Distant metastases;
- Recurrent rectal cancer;
- Active Crohn's disease or ulcerative colitis;
- Concomitant malignancies;(except basocellular carcinoma or in-situ cervical carcinoma)
- Allergic to Fluorouracil or Platinum drugs;
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 |
|---|---|---|
| Short-course radiotherapy with neoadjuvant chemotherapyShort-course radiotherapy with 4 cycles of neoadjuvant chemotherapy | Radiation | TNT group |
| Long-term chemoradiotherapyStandard chemoradiotherapy | Radiation | CRT group |
Primary outcome
Disease-free survival rate
Time frame: three year
8 secondary outcomes
Overall survival rate
Time frame: three year
Distance metastasis free survival rate
Time frame: three year
Locoregional recurrence free survival rate
Time frame: three year
Incidence of surgical complications
Time frame: one month
Incidence of acute toxicities during radiation or chemotherapy
Time frame: three months
Radical resection (R0)
Time frame: one year
The rate of pathological complete response (pCR)
Time frame: one year
Quality of life (QoL)
Time frame: up to three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Derived from this study: PubMed 42507974Tang Y, Zhou HT, Xu TZ, Li N, Jiang LM, Jiang J, Lu NN, Li S, Chen SL, Ma HY, Cai Y, Li YH, Zhu Y, He MY, Wang X, Liu K, Zhang HY, Wang J, Zhao T, Li GF, Yang JL, Zhang K, Wang WL, Xiao WW, Chi Y, Yang L, Zhou AP, Zou SM, Fang H, Wang SL, Zhang HZ, Wang XS, Wei LC, Liu SX, Gao YH, Li YX, Hu C, Jin J. Five-Year Outcomes of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy for Locally Advanced Rectal Cancer: Updated Results of the STELLAR Trial. J Clin Oncol. 2026 Sep;44(25):2371-2378. doi: 10.1200/JCO-25-02387. Epub 2026 Jul 27.
- Derived from this study: PubMed 42142768Wang N, Xu T, Li H, Shuai J, Ma H, Fang H, Song Y, Chen B, Lu N, Jing H, Liu X, Qi S, Zhang W, Liu Y, Li Y, Wang S, Dou L, Jin J, Tang Y. Diabetes and Performance Status Predict Severe, Persistent Radiation Proctitis: Long-Term Endoscopic Findings From STELLAR Trial. Int J Radiat Oncol Biol Phys. 2026 May 15:S0360-3016(26)00722-4. doi: 10.1016/j.ijrobp.2026.05.004. Online ahead of print.
- Derived from this study: PubMed 41742206Xu T, Ma H, Zhang W, Yang Y, Xiao W, Li N, Li H, Gao Y, Liu S, Wei L, Jiang L, Shi J, Shuai J, Cai Y, Li Y, Cheng G, Luo W, Wang X, Liu K, Wang J, Lu N, Fang H, Liu Y, Song Y, Zhang W, Wang S, Li Y, Zhou A, Zhou H, Chi Y, Tang Y, Jin J. Minimum 18-week chemotherapy improves survival in locally advanced rectal cancer after neoadjuvant radiotherapy: a post hoc analysis of the STELLAR trial. BMC Med. 2026 Feb 25;24(1):190. doi: 10.1186/s12916-026-04731-0.
- Derived from this study: PubMed 39243864Ma H, Li H, Xu T, Gao Y, Liu S, Wang W, Wei L, Wang X, Jiang L, Chi Y, Shi J, Shuai J, Zou S, Cai Y, Zhu Y, Cheng G, Zhang H, Wang X, Zhu S, Wang J, Li G, Yang J, Zhang K, Lu N, Fang H, Wang S, Li Y, Zhou H, Tang Y, Jin J. Multidisciplinary team quality improves the survival outcomes of locally advanced rectal cancer patients: A post hoc analysis of the STELLAR trial. Radiother Oncol. 2024 Nov;200:110524. doi: 10.1016/j.radonc.2024.110524. Epub 2024 Sep 5.
- Derived from this study: PubMed 35263150Jin J, Tang Y, Hu C, Jiang LM, Jiang J, Li N, Liu WY, Chen SL, Li S, Lu NN, Cai Y, Li YH, Zhu Y, Cheng GH, Zhang HY, Wang X, Zhu SY, Wang J, Li GF, Yang JL, Zhang K, Chi Y, Yang L, Zhou HT, Zhou AP, Zou SM, Fang H, Wang SL, Zhang HZ, Wang XS, Wei LC, Wang WL, Liu SX, Gao YH, Li YX. Multicenter, Randomized, Phase III Trial of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy in Locally Advanced Rectal Cancer (STELLAR). J Clin Oncol. 2022 May 20;40(15):1681-1692. doi: 10.1200/JCO.21.01667. Epub 2022 Mar 9.
- 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.
Jing Jin study director
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Short-course radiotherapy with neoadjuvant chemotherapy and Long-term chemoradiotherapy in people with Cancer, Rectum, run by Chinese Academy of Medical Sciences at 1 site in China.
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 9 inclusion and 10 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 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yuan Tang (+86-15011304945, tangyuan82@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival rate (time frame: three year). 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 NCT02533271, which also lists 5 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 16 Jul 2021.