Preoperative Hyperfractionated Radiotherapy or Radiochemotherapy in Locally Advanced Rectal Cancer.

NCT01814969 | Unknown Phase 3 DMC

• 1 other identifier: PHRT-COI-01
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer

Keywords

Rectal neoplasm; Preoperative hyperfractionated radiotherapy; Preoperative hyperfractionated radiochemotherapy

Outcome Measures

Primary Outcomes (1)

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

  Surrogate endpoint available immediatly after surgery

Secondary Outcomes (7)

• The rate of local failures

  3 years

• Progression-free long-term survival

  3 years

• The rate of distant metastases

  3 years

• Overall long-term survival

  3 years

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

  3 years

Study Arms (2)

Hyperfractionated Radiochemotherapy

EXPERIMENTAL

radiotherapy 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).

Radiation: Hyperfractionated Radiochemotherapy

Hyperfractionated Radiotherapy

ACTIVE COMPARATOR

radiotherapy 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).

Radiation: Hyperfractionated Radiotherapy

Interventions

Hyperfractionated Radiochemotherapy RADIATION

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).

Also known as: Hyperfractionated Radiochemotherapy (HRTCT)

Hyperfractionated Radiochemotherapy

Hyperfractionated Radiotherapy RADIATION

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

Also known as: Hyperfractionated Radiotherapy (HRT)

Hyperfractionated Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Karnofsky Index 80% or better (Zubrod 0-1)
• Histological proved diagnosis of rectal cancer (adeno- or mucinous carcinoma)
• Primary rectal cancer:
• 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
• 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).

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (1)

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

Gliwice, Wybrzeze AK 15, 44-100, Poland

RECRUITING

Related Publications (5)

• 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.

  PMID: 17499451 BACKGROUND

• 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.

  PMID: 16730087 BACKGROUND

• 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.

  PMID: 21377377 BACKGROUND

• 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.

  PMID: 33618522 DERIVED

• 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.

  PMID: 28466686 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Rafal Suwinski, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Idasiak, MD

CONTACT

+4832278819; aidasiak@op.pl

Rafal Suwinski, MD

CONTACT

+48322788805; rafals@io.gliwice.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 20, 2013
• Study Start: March 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2018
• Last Updated: May 5, 2015

Record last verified: 2015-05

Locations

PL (1)