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AzTrials

Rectal CancerPhase 3NCT02843191

Consolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After Neoadjuvant Concurrent Chemoradiotherapy

A Phase 3 study testing Chemotherapy in people with Rectal Cancer, run by Kyung Hee University Hospital at Gangdong at 14 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This trial is to assess the efficacy and feasibility of consolidation chemotherapy after neoadjuvant chemoradiotherapy for locally advanced mid or low rectal cancer. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Rectal Cancer
What is being tested?
Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
358 participants
Where
14 sitesSouth Korea
Study dates
7 Dec 2016to 30 Jun 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed adenocarcinoma of mid or low rectum
  • Locally advanced rectal cancer confirmed by image (i.e. Magnetic resonance image)
  • Clinical stage T1-3N1or2 on MRI
  • Clinical stage cT3N0 (or depth of perirectal invasion by tumor >5mm on MRI)
  • Suspicious of circumferential invasion on MRI (or circumferential margin <1mm)
  • ECOG performance status of 0-2
  • ASA grade ≤ 3
  • An informed consent has been signed by the patient

Who cannot join

  • Upper rectal cancer
  • Clinical stage T1or2N0 on MRI
  • Clinical stage T4Nany on MRI
  • Clinical stage TanyNanyM1 by image or histology
  • The patient received chemotherapy or radiotherapy during the past 6 months
  • The patient received any therapy for colorectal cancer or another malignancy during the past 5 years
Show all 13Show fewer
  • The patient has severe underlying diseases or poor condition to receive chemotherapy or radiotherapy
  • Pregnant of breastfeeding women
  • The patient who participate in another clinical trial, or receives any drug for the trial
  • Uncontrolled peripheral neuropathy (more than grade 2)
  • Any unhealed wound, fracture, peptic ulcer, or intraabdominal abscess
  • Active gastrointestinal bleeding
  • Patients with an active infection, which needs antibiotic therapy, during the randomization period

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

South Korea14 sites

  • Inje University Busan Paik hospital

    Busan, 47392

  • Soonchunhyang University Cheonan Hospital

    Cheonan, 31151

  • Chuncheon Sacred Heart Hospital, Hallym University College of Medicine

    Chuncheon, 24253

  • Keimyung University Dongsan Medical Center

    Daegu, 41931

  • Chungnam National University Hospital

    Daejeon, 35015

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128

  • Wonkwang University Hospital

    Iksan, 54538

  • Inje University Sanggye Paik Hospital

    Seoul, 01757

  • Gangnam Severance Hospital, Yonsei University College of Medicine

    Seoul, 06273

  • Seoul St. Mary's Hospital, The Catholic University College of Medicine

    Seoul, 06591

  • Ajou University School of Medicine

    Suwon, 16499

  • Uijeongbu St. Mary's Hospital, The Catholic University College of Medicine

    Uijeongbu-si, 11765

  • Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine

    Wŏnju, 26426

  • Pusan National University Yangsan Hospital

    Yangsan, 50612

Other trials in South Korea

About this study

Official title: KCSP Trial of CONsolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After NeoadjUvant Concurrent ChemoraDiothErapy: a Multicenter, Randomized Controlled Trial (KONCLUDE)

This trial is to assess the efficacy and feasibility of consolidation chemotherapy after neoadjuvant chemoradiotherapy for locally advanced mid or low rectal cancer.

Conditions
Rectal Cancer
Being tested
Chemotherapy
Keywords
Rectal Cancer, Consolidation Chemotherapy
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • ChemotherapyDrug

    5-FU, Leucovorin, and Oxaliplatin (FOLFOX regimen)

Study groups in NCT02843191
Study groupRoleWhat they receive
Adjuvant chemotherapyActive comparatorAfter neoadjuvant chemoradiotherapy, patients will receive surgery followed by eight cycles of chemotherapy.
Receives: Drug: Chemotherapy
Consolidation chemotherapyExperimentalAfter neoadjuvant chemoradiotherapy, patients will receive three cycles of chemotherapy. Thereafter, they will receive surgery followed by five cycles of chemotherapy.
Receives: Drug: Chemotherapy

What is being measured

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

  1. Pathologic complete response

    Pathologic complete response is defined as no residual tumor on the surgical specimen after chemoradiotherapy. (i.e. Mandard grade 1 or Dworak grade 4)

    Measured: 2 years

  2. Disease-free survival

    The rates of patients who survive without recurrence

    Measured: 3 years

Secondary outcomes (5)

  1. Radiotherapy-related complications

    Complications according to the CTCAE 4.0

    Measured: 2 years

  2. R0 resection

    R0 resection is defined as resection without remnant tumor, whereas R1 resection as microscopic residual tumor and R2 resection as gross residual tumor. R0 resection will be proven histologically as no resection margin involvement of tumor.

    Measured: 2 years

  3. Tumor response rate

    Amount of tumor regression after surgery according to the guideline including Mandard or Dworak

    Measured: 2 years

  4. Postoperative complications

    Complications after surgery

    Measured: 2 years

  5. Peripheral neuropathy

    Peripheral neuropathy will be evaluated as grade 1 to 4 according to NCI CTCAE 4.0.

    Measured: 3 years

Timeline

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

  1. First posted25 Jul 2016 (estimated)
  2. Study start7 Dec 2016
  3. Primary completion15 Jul 2023
  4. Study completion30 Jun 2026 (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
358 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02843191
Sponsor's protocol ID
KSCP2016
Status last verified
Dec 2024
First submitted
19 Jul 2016
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 15496622

  • Heald RJ, Ryall RD. Recurrence and survival after total mesorectal excision for rectal cancer. Lancet. 1986 Jun 28;1(8496):1479-82. doi: 10.1016/s0140-6736(86)91510-2.

    PubMed 2425199

  • Kapiteijn E, Kranenbarg EK, Steup WH, Taat CW, Rutten HJ, Wiggers T, van Krieken JH, Hermans J, Leer JW, van de Velde CJ. Total mesorectal excision (TME) with or without preoperative radiotherapy in the treatment of primary rectal cancer. Prospective randomised trial with standard operative and histopathological techniques. Dutch ColoRectal Cancer Group. Eur J Surg. 1999 May;165(5):410-20. doi: 10.1080/110241599750006613.

    PubMed 10391155

  • 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.

    PubMed 21596621

  • Gerard JP, Conroy T, Bonnetain F, Bouche O, Chapet O, Closon-Dejardin MT, Untereiner M, Leduc B, Francois E, Maurel J, Seitz JF, Buecher B, Mackiewicz R, Ducreux M, Bedenne L. Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers: results of FFCD 9203. J Clin Oncol. 2006 Oct 1;24(28):4620-5. doi: 10.1200/JCO.2006.06.7629.

    PubMed 17008704

  • 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.

    PubMed 22529255

  • Gastrointestinal Tumor Study Group. Prolongation of the disease-free interval in surgically treated rectal carcinoma. N Engl J Med. 1985 Jun 6;312(23):1465-72. doi: 10.1056/NEJM198506063122301.

    PubMed 2859523

  • Bosset JF, Collette L, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, Daban A, Bardet E, Beny A, Ollier JC; EORTC Radiotherapy Group Trial 22921. Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med. 2006 Sep 14;355(11):1114-23. doi: 10.1056/NEJMoa060829.

    PubMed 16971718

  • Roh MS, Colangelo LH, O'Connell MJ, Yothers G, Deutsch M, Allegra CJ, Kahlenberg MS, Baez-Diaz L, Ursiny CS, Petrelli NJ, Wolmark N. Preoperative multimodality therapy improves disease-free survival in patients with carcinoma of the rectum: NSABP R-03. J Clin Oncol. 2009 Nov 1;27(31):5124-30. doi: 10.1200/JCO.2009.22.0467. Epub 2009 Sep 21.

    PubMed 19770376

  • Kapiteijn E, Marijnen CA, Nagtegaal ID, Putter H, Steup WH, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van Krieken JH, Leer JW, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med. 2001 Aug 30;345(9):638-46. doi: 10.1056/NEJMoa010580.

    PubMed 11547717

  • Valentini V, Coco C, Picciocchi A, Morganti AG, Trodella L, Ciabattoni A, Cellini F, Barbaro B, Cogliandolo S, Nuzzo G, Doglietto GB, Ambesi-Impiombato F, Cosimelli M. Does downstaging predict improved outcome after preoperative chemoradiation for extraperitoneal locally advanced rectal cancer? A long-term analysis of 165 patients. Int J Radiat Oncol Biol Phys. 2002 Jul 1;53(3):664-74. doi: 10.1016/s0360-3016(02)02764-5.

    PubMed 12062610

  • Rodel C, Martus P, Papadoupolos T, Fuzesi L, Klimpfinger M, Fietkau R, Liersch T, Hohenberger W, Raab R, Sauer R, Wittekind C. Prognostic significance of tumor regression after preoperative chemoradiotherapy for rectal cancer. J Clin Oncol. 2005 Dec 1;23(34):8688-96. doi: 10.1200/JCO.2005.02.1329. Epub 2005 Oct 24.

    PubMed 16246976

  • Mandard AM, Dalibard F, Mandard JC, Marnay J, Henry-Amar M, Petiot JF, Roussel A, Jacob JH, Segol P, Samama G, et al. Pathologic assessment of tumor regression after preoperative chemoradiotherapy of esophageal carcinoma. Clinicopathologic correlations. Cancer. 1994 Jun 1;73(11):2680-6. doi: 10.1002/1097-0142(19940601)73:113.0.co;2-c.

    PubMed 8194005

  • Garcia-Aguilar J, Hernandez de Anda E, Sirivongs P, Lee SH, Madoff RD, Rothenberger DA. A pathologic complete response to preoperative chemoradiation is associated with lower local recurrence and improved survival in rectal cancer patients treated by mesorectal excision. Dis Colon Rectum. 2003 Mar;46(3):298-304. doi: 10.1007/s10350-004-6545-x.

    PubMed 12626903

  • Dworak O, Keilholz L, Hoffmann A. Pathological features of rectal cancer after preoperative radiochemotherapy. Int J Colorectal Dis. 1997;12(1):19-23. doi: 10.1007/s003840050072.

    PubMed 9112145

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chemotherapy in people with Rectal Cancer, run by Kyung Hee University Hospital at Gangdong at 14 sites in South Korea.

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 8 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in South Korea. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic complete response (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT02843191, which also lists 26 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 27 Dec 2024.

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