NCT02498353

Brief Summary

A randomized trial comparing weather preoperative short-course radiotherapy with local boost is better than conventional preoperative short-course radiotherapy for local advanced rectal cancer.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

July 15, 2015

Status Verified

July 1, 2015

Enrollment Period

4.8 years

First QC Date

June 28, 2015

Last Update Submit

July 10, 2015

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • pathological complete remission rate

    4 weeks after the surgery

Secondary Outcomes (3)

  • disease free survival

    From date of randomization until the date of first documented progression，assessed up to 60 months

  • sphincter retention rate

    4 weeks after the surgery

  • toxicity of radiotherapy based on the CTCAE v3.0 (common terminology criteria for adverse events，CTCAE v3.0)

    up to 60 months

Study Arms (2)

study group

EXPERIMENTAL

Preoperative short-course radiotherapy with local boost ,the dose of radiotherapy is PTV-CTV 25Gy/5F with local boost of PTV-GTV 30Gy/5F. TME surgery after radiotherapy.

Radiation: preoperative short-course radiotherapy with local boostProcedure: TME surgery

control group

ACTIVE COMPARATOR

Preoperative short-course radiotherapy without local boost,the dose of radiotherapy is PTV-CTV 25Gy/5F without local boost. TME surgery after radiotherapy.

Radiation: preoperative short-course radiotherapy without local boostProcedure: TME surgery

Interventions

preoperative short-course radiotherapy with local boostRADIATION

Except the clinical target volume(CTV),a gross tumour volume（GTV）is delineated，and give a dose of PTV-GTV:30Gy/5F

study group
preoperative short-course radiotherapy without local boostRADIATION

Preoperative short-course radiotherapy without local boost,the dose of radiotherapy is PTV-CTV 25Gy/5F

control group
TME surgeryPROCEDURE

both study group and control group received surgery under TME principle after radiotherapy

control groupstudy group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Local advanced rectal cancer (TNM Stage ：T3-4NxM0 )diagnosed by biopsy and MRI or Endoscopic ultrasonography .
  • distance between tumour and anal edge ≤12cm.
  • PS（(Performance Status） score 0-2 or Karnofsky score≥70.
  • liver and kidney functions are normal.

You may not qualify if:

  • metastasis
  • combined with other severe diseases，such as other kind of cancer ,COPD,myocardial infarction,ect.
  • include in other clinical trails.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Inra JA, Syngal S. Colorectal cancer in young adults. Dig Dis Sci. 2015 Mar;60(3):722-33. doi: 10.1007/s10620-014-3464-0. Epub 2014 Dec 6.

    PMID: 25480403RESULT

  • Sauer R, Fietkau R, Wittekind C, Rodel C, Martus P, Hohenberger W, Tschmelitsch J, Sabitzer H, Karstens JH, Becker H, Hess C, Raab R; German Rectal Cancer Group. Adjuvant vs. neoadjuvant radiochemotherapy for locally advanced rectal cancer: the German trial CAO/ARO/AIO-94. Colorectal Dis. 2003 Sep;5(5):406-15. doi: 10.1046/j.1463-1318.2003.00509.x.

    PMID: 12925071RESULT

  • Sauer R, Liersch T, Merkel S, Fietkau R, Hohenberger W, Hess C, Becker H, Raab HR, Villanueva MT, Witzigmann H, Wittekind C, Beissbarth T, Rodel C. Preoperative versus postoperative chemoradiotherapy for locally advanced rectal cancer: results of the German CAO/ARO/AIO-94 randomized phase III trial after a median follow-up of 11 years. J Clin Oncol. 2012 Jun 1;30(16):1926-33. doi: 10.1200/JCO.2011.40.1836. Epub 2012 Apr 23.

    PMID: 22529255RESULT

  • Folkesson J, Birgisson H, Pahlman L, Cedermark B, Glimelius B, Gunnarsson U. Swedish Rectal Cancer Trial: long lasting benefits from radiotherapy on survival and local recurrence rate. J Clin Oncol. 2005 Aug 20;23(24):5644-50. doi: 10.1200/JCO.2005.08.144.

    PMID: 16110023RESULT

  • Guckenberger M, Saur G, Wehner D, Thalheimer A, Kim M, Germer CT, Flentje M. Long-term quality-of-life after neoadjuvant short-course radiotherapy and long-course radiochemotherapy for locally advanced rectal cancer. Radiother Oncol. 2013 Aug;108(2):326-30. doi: 10.1016/j.radonc.2013.08.022. Epub 2013 Sep 7.

    PMID: 24021342RESULT

  • Peeters KC, Marijnen CA, Nagtegaal ID, Kranenbarg EK, Putter H, Wiggers T, Rutten H, Pahlman L, Glimelius B, Leer JW, van de Velde CJ; Dutch Colorectal Cancer Group. The TME trial after a median follow-up of 6 years: increased local control but no survival benefit in irradiated patients with resectable rectal carcinoma. Ann Surg. 2007 Nov;246(5):693-701. doi: 10.1097/01.sla.0000257358.56863.ce.

    PMID: 17968156RESULT

  • Sauer R, Becker H, Hohenberger W, Rodel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40. doi: 10.1056/NEJMoa040694.

    PMID: 15496622RESULT

  • Sebag-Montefiore D, Stephens RJ, Steele R, Monson J, Grieve R, Khanna S, Quirke P, Couture J, de Metz C, Myint AS, Bessell E, Griffiths G, Thompson LC, Parmar M. Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial. Lancet. 2009 Mar 7;373(9666):811-20. doi: 10.1016/S0140-6736(09)60484-0.

    PMID: 19269519RESULT

  • van Gijn W, Marijnen CA, Nagtegaal ID, Kranenbarg EM, Putter H, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 12-year follow-up of the multicentre, randomised controlled TME trial. Lancet Oncol. 2011 Jun;12(6):575-82. doi: 10.1016/S1470-2045(11)70097-3. Epub 2011 May 17.

    PMID: 21596621RESULT

  • Ngan SY, Burmeister B, Fisher RJ, Solomon M, Goldstein D, Joseph D, Ackland SP, Schache D, McClure B, McLachlan SA, McKendrick J, Leong T, Hartopeanu C, Zalcberg J, Mackay J. Randomized trial of short-course radiotherapy versus long-course chemoradiation comparing rates of local recurrence in patients with T3 rectal cancer: Trans-Tasman Radiation Oncology Group trial 01.04. J Clin Oncol. 2012 Nov 1;30(31):3827-33. doi: 10.1200/JCO.2012.42.9597. Epub 2012 Sep 24.

    PMID: 23008301RESULT

  • Ortholan C, Romestaing P, Chapet O, Gerard JP. Correlation in rectal cancer between clinical tumor response after neoadjuvant radiotherapy and sphincter or organ preservation: 10-year results of the Lyon R 96-02 randomized trial. Int J Radiat Oncol Biol Phys. 2012 Jun 1;83(2):e165-71. doi: 10.1016/j.ijrobp.2011.12.002.

    PMID: 22579379RESULT

  • Faria S, Kopek N, Hijal T, Liberman S, Charlebois P, Stein B, Meterissian S, Meguerditchian A, Fawaz Z, Artho G. Phase II trial of short-course radiotherapy followed by delayed surgery for locoregionally advanced rectal cancer. Colorectal Dis. 2014 Feb;16(2):O66-70. doi: 10.1111/codi.12466.

    PMID: 24148225RESULT

  • Bujko K, Partycki M, Pietrzak L. Neoadjuvant radiotherapy (5 x 5 Gy): immediate versus delayed surgery. Recent Results Cancer Res. 2014;203:171-87. doi: 10.1007/978-3-319-08060-4_12.

    PMID: 25103005RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Fuxiang Zhou, professor

    Zhongnan Hospital

    STUDY DIRECTOR

Central Study Contacts

Fuxiang Zhou, professor

CONTACT

8618971252780happyzhoufx@sina.com

Ling Xia, doctor

CONTACT

861897125071622425583@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 28, 2015

First Posted

July 15, 2015

Study Start

July 1, 2015

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

July 15, 2015

Record last verified: 2015-07