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AzTrials

Rectal CancerPhase 3NCT01814969

Preoperative Hyperfractionated Radiotherapy or Radiochemotherapy in Locally Advanced Rectal Cancer.

A Phase 3 study testing Hyperfractionated Radiochemotherapy and Hyperfractionated Radiotherapy in people with Rectal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Clinical objective of the study is to compare the rates of pathologic response, acute toxicity and sphincter preservation with two schedules of preoperative regiment in patients with locally advanced rectal cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rectal Cancer
What is being tested?
Hyperfractionated Radiochemotherapy and Hyperfractionated Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
1 sitePoland
Study dates
Mar 2014to Dec 2018
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Karnofsky Index 80% or better (Zubrod 0-1)
  • Histological proved diagnosis of rectal cancer (adeno- or mucinous carcinoma)
  • Primary rectal cancer:
  • 3.1. Maximum 12 cm above dentate line (upper limit) 3.2. Staged T2N+ or T3N0 or T3N+ (by endorectal ultrasound or Computed Tomography [CT]/Magnetic Resonance Imaging [MRI] scan)
  • No evidence of metastatic disease as determined by chest X-ray and abdominal ultrasound (or CT-scan of chest and abdomen or other investigations such as Positron Emission Tomography [PET] scan or biopsy if required)
  • Adequate bone marrow function with platelets more than 100 × 10^9/l and neutrophils more than 2.0 × 10^9/l
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  • Creatinine clearance more than 50 ml/min
  • Serum bilirubin less than 2.0 × Upper Limit of institutional Normal range (ULN)
  • Written informed consent is obtained prior to commencement of trial treatment (confirmed the signature on the consent form for the proposed project and the standard medical consent form for radiotherapy within the abdominal cavity).

Who cannot join

  • Rectal cancer other than adeno- or mucinous carcinoma
  • Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin
  • Patients with locally advanced inoperable disease, such as T4-tumour
  • Presence of metastatic disease or recurrent rectal tumour
  • Any previous chemotherapy or radiotherapy, and any investigational treatment for rectal cancer
  • Concurrent uncontrolled medical conditions
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  • Pregnancy or breast feeding
  • Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease) or myocardial infarction within the last six months
  • Evidence of hereditary colorectal cancer (Hereditary Non-Polyposis Colorectal Cancer [HNPCC] and Familial Adenomatous Polyposis [FAP])
  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent
  • No agreement for randomisation

Trial locations and contacts

1 site in 1 country.

Adam Idasiak, MD contact

+4832278819

aidasiak@op.pl

Rafal Suwinski, MD contact

+48322788805

rafals@io.gliwice.pl

Poland1 site, 1 recruiting

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch

    Gliwice, Wybrzeze AK 15, 44-100

    Adam Idasiak, MD, +48322788819, aidasiak@op.pl

    Rafal Suwinski, MD, PhD

    Recruiting

Other trials in Poland

About this study

Official title: Preoperative Hyperfractionated Radiotherapy Versus Combined Radiochemotherapy for Patients With Locally Advanced Rectal Cancer: a Phase III Randomized Trial.

Clinical objective of the study is to compare the rates of pathologic response, acute toxicity and sphincter preservation with two schedules of preoperative regiment in patients with locally advanced rectal cancer.

Read the detailed description

Overview of randomized trials conducted in patients with advanced colorectal cancer with the use of preoperative radiotherapy or radiochemotherapy clearly shows the superiority of combined therapy over surgery alone. In these studies documented a significant reduction in tumor mass as a result of preoperative radiotherapy or radiochemotherapy theoretically increases the chance of performing operations with sphincters preservation, even in cases originally eligible for abdomino - perineal resection. There is the question whether the combination of preoperative hyperfractionated radiotherapy and concurrent chemotherapy may cause the further improvement of treatment outcome in patients with locally advanced rectal cancer. Published in 2012 by Gerard et al. meta-analysis of randomized trials dedicated to the treatment of patients with advanced colorectal cancer, confirms a higher percentage of sphincters preservation in patients operated after more than 5-week interval between neoadjuvant therapy and surgery.

Analysis of these issues will be taken in the current study. Comparison of the two treatment regimens as preoperative phase III study with stratification for time interval between the end of radiotherapy or radiochemotherapy and surgery may show differences that have not been seen in previously published data.

Conditions
Rectal Cancer
Being tested
Hyperfractionated Radiochemotherapy, Hyperfractionated Radiotherapy
Keywords
Rectal neoplasm, Preoperative hyperfractionated radiotherapy, Preoperative hyperfractionated radiochemotherapy
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyperfractionated RadiochemotherapyRadiation

    Also called Hyperfractionated Radiochemotherapy (HRTCT)

    28 x 1.5Gy 2 times a day; gap between the fractions min. 6-8h - duration of treatment 2.5 weeks + simultaneous bolus 5-Fluorouracil (the each cycle consisted of 5-fluorouracil 325 mg/m2 per day) on 1-3 and 16-18 (last 3 days of radiotherapy).

  • Hyperfractionated RadiotherapyRadiation

    Also called Hyperfractionated Radiotherapy (HRT)

    28 x 1.5Gy 2 times a day; gap between the factions min. 6-8h - duration of treatment 2.5 weeks

Study groups in NCT01814969
Study groupRoleWhat they receive
Hyperfractionated RadiochemotherapyExperimentalradiotherapy in rectal tumor area due to the placing of pelvic nodal groups to a total dose of 42 Gy, 1.5 Gy d fx 2 times a day; (gap between the factions min. 6-8h) - duration of treatment 2.5 weeks with simultaneous two cycles of chemotherapy according to the scheme: 5FU-325mg/m2 (bolus) on 1-3 and 16-18 (last 3 days of radiotherapy). Surgical resection has to be done within 14 days or 5-6 weeks after the completion of hyperfractionated radiochemotherapy (HRTCT).
Receives: Radiation: Hyperfractionated Radiochemotherapy
Hyperfractionated RadiotherapyActive comparatorradiotherapy in rectal tumor area due to the placing of pelvic nodal groups to a total dose of 42 Gy, 1.5 Gy d fx 2 times a day; (gap between the factions min. 6-8h) - duration of treatment 2.5 weeks. Surgical resection has to be done within 14 days or 5-6 weeks after the completion of hyperfractionated radiotherapy (HRT).
Receives: Radiation: Hyperfractionated Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. • The rate of patients with downstaging after radiotherapy or radiochemotherapy to pathological response or disease with negative margins

    Measured: Surrogate endpoint available immediatly after surgery

Secondary outcomes (7)

  1. The rate of local failures

    Measured: 3 years

  2. Progression-free long-term survival

    Measured: 3 years

  3. The rate of distant metastases

    Measured: 3 years

  4. Overall long-term survival

    Measured: 3 years

  5. The rate of late toxicity according to the RTOG/EORTC scale

    Measured: 3 years

  6. The rate of postoperative complications

    Measured: 3 months

  7. The rate of early toxicity of neoadjuvant treatment according to the NCI CTCAE (version 4.0)

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2013 (estimated)
  2. Study startMar 2014
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

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
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01814969
Sponsor's protocol ID
PHRT-COI-01
Status last verified
May 2015
First submitted
18 Mar 2013
Last updated
5 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Suwinski R, Wzietek I, Tarnawski R, Namysl-Kaletka A, Kryj M, Chmielarz A, Wydmanski J. Moderately low alpha/beta ratio for rectal cancer may best explain the outcome of three fractionation schedules of preoperative radiotherapy. Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):793-9. doi: 10.1016/j.ijrobp.2007.03.046. Epub 2007 May 17.

    PubMed 17499451

  • Suwinski R, Wydmanski J, Pawelczyk I, Starzewski J. A pilot study of accelerated preoperative hyperfractionated pelvic irradiation with or without low-dose preoperative prophylactic liver irradiation in patients with locally advanced rectal cancer. Radiother Oncol. 2006 Jul;80(1):27-32. doi: 10.1016/j.radonc.2006.05.001. Epub 2006 May 26.

    PubMed 16730087

  • Gerard JP, Rostom Y, Gal J, Benchimol D, Ortholan C, Aschele C, Levi JM. Can we increase the chance of sphincter saving surgery in rectal cancer with neoadjuvant treatments: lessons from a systematic review of recent randomized trials. Crit Rev Oncol Hematol. 2012 Jan;81(1):21-8. doi: 10.1016/j.critrevonc.2011.02.001. Epub 2011 Mar 5.

    PubMed 21377377

  • Idasiak A, Galwas-Kliber K, Rajczykowski M, Debosz-Suwinska I, Zeman M, Stobiecka E, Mrochem-Kwarciak J, Suwinski R. Tumor regression grading after preoperative hyperfractionated radiotherapy/chemoradiotherapy for locally advanced rectal cancers: interim analysis of phase III clinical study. Neoplasma. 2021 May;68(3):631-637. doi: 10.4149/neo_2021_201217N1366. Epub 2021 Feb 24.

    PubMed 33618522

  • Idasiak A, Galwas-Kliber K, Behrendt K, Wzietek I, Kryj M, Stobiecka E, Chmielik E, Suwinski R. Pre-operative hyperfractionated concurrent radiochemotherapy for locally advanced rectal cancers: a phase II clinical study. Br J Radiol. 2017 Jun;90(1074):20160731. doi: 10.1259/bjr.20160731. Epub 2017 May 23.

    PubMed 28466686

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hyperfractionated Radiochemotherapy and Hyperfractionated Radiotherapy in people with Rectal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.

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 11 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 5 May 2015. 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 Poland. 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 Adam Idasiak, MD (+4832278819, aidasiak@op.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

• The rate of patients with downstaging after radiotherapy or radiochemotherapy to pathological response or disease with negative margins (time frame: Surrogate endpoint available immediatly after surgery). 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 NCT01814969, 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 5 May 2015.

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