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AzTrials

Colorectal CancerPhase 3PARADIGMNCT02394795

Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC

A Phase 3 study testing oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab and oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab in people with Colorectal Cancer, run by Takeda at 155 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to verify the efficacy of mFOLFOX6 + panitumumab combination therapy and mFOLFOX6 + bevacizumab combination therapy in first-line treatment of chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer. Read more about this study

Who is it for?
Ages 20 to 79 years
Conditions the study is for
Colorectal Cancer
What is being tested?
oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab and oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
823 participants
Where
155 sitesJapan
Study dates
29 May 2015to 14 Jan 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Investigator and subinvestigator judge a candidate is understand clinical trial and comply this protocol.
  • Investigator is those who participate in conducting a study and oversight the study duties at a site.
  • Patients who have given written consent to take part in the study after detailed explanation of the study prior to enrollment
  • Aged ≥20 to <80 years at the time of informed consent
  • Patients with unresectable adenocarcinoma originating in the large intestine (excluding carcinoma of the appendix and anal canal cancer)
  • Patients with lesion(s) that can be evaluated. It is not essential to be evaluated the tumor according to the RECIST ver. 1.1.
Show all 25Show fewer
  • Patients who have not received chemotherapy for colorectal cancer. Patients who experience relapse more than 24 weeks (168 days) after the final dose of perioperative adjuvant chemotherapy with fluoropyrimidine agents may be enrolled. Patients who have received perioperative adjuvant chemotherapy including oxaliplatin are excluded.
  • Patients classified as KRAS/NRAS wild-type by KRAS/NRAS testing. KRAS/NRAS test will be performed using the in vitro diagnostic listed in the National Health Insurance.
  • Patients with no mutation in any of the codons shown below are considered wild type. It is not considered wild type if either of the codons are not evaluable or not tested.
  • KRAS: EXON2 (codon 12, 13), EXON3 (codon 59, 61), EXON4 (codon 117, 146) NRAS：EXON2 (codon 12, 13), EXON3 (codon 59, 61), EXON4 (codon 117, 146)
  • Patients who satisfy the following criteria for the major organ function in tests performed within 14 days prior to enrollment
  • Neutrophil count ≥ 1.5×10^3/µL
  • Platelet count ≥ 1.0×10^4/µL
  • Hemoglobin ≥ 9.0 g/dL
  • Total bilirubin ≤ 2.0 mg/dL
  • AST ≤ 100 IU/L (≤ 200 IU/L if liver metastases are present)
  • ALT ≤ 100 IU/L (≤ 200 IU/L if liver metastases are present)
  • Serum creatinine ≤ 1.5 mg/dL
  • PT-INR < 1.5 (< 3.0 for patients treated with oral warfarin)
  • Satisfies at least one of these conditions
  • Urine protein (dip stick method) ≤ 1+
  • UPC (urine protein creatinine) ratio ≤ 1.0
  • Urinary protein ≤ 1000 mg/ 24hours
  • ECOG performance status (PS) of 0 or 1
  • Life expectancy of ≥ 3 months (90 days) after enrollment

Who cannot join

  • Radiotherapy received within 4 weeks (28 days) prior to enrollment. Treatments aimed at relieving pain for bone metastases are excluded.
  • Known brain metastasis or strongly suspected of brain metastasis
  • Synchronous cancers or metachronous cancers with a disease-free period of ≤ 5 years (excluding colorectal cancer) excluding mucosal cancers cured or be possibly cured by regional resection (esophageal, stomach, and cervical cancer, non-melanoma skin cancer, bladder cancer, etc.).
  • Body cavity fluid that requires treatment (pleural effusion, ascites, pericardial effusion, etc.)
  • Patients who do not want to use contraception to prevent pregnancy, and women who are pregnant or breast-feeding, or test positive for pregnancy
  • Nonhealing surgical wound (excluding implanted venous reservoirs)
Show all 22Show fewer
  • Active hemorrhage requiring blood transfusion
  • Disease requiring systemic steroids for treatment (excluding topical steroids)
  • The patient who has placed colonic stent
  • Intestinal resection within 4 weeks prior to enrollment or colostomy within 2 weeks prior to enrollmentt
  • History or obvious and extensive CT findings of interstitial pulmonary disease (interstitial pneumonia, pulmonary fibrosis, etc.)
  • Patients with unstable angina, myocardial infarction, cerebral hemorrhage, arterial thromboembolism such as cerebral infarction, or have history of these desease less than 24 weeks (168 days) before registration (except for lacunar infarction asymptomatic)
  • Serious drug hypersensitivity
  • Local or systemic active infection requiring treatment, or fever indicating infection
  • NYHA class II or higher heart failure or serious heart disease
  • Intestinal paralysis, gastrointestinal obstruction, or uncontrollable diarrhoea (incapacitating symptoms despite adequate treatment)
  • Poorly controlled hypertension
  • Poorly controlled diabetes mellitus
  • Active hepatitis B
  • Known HIV infection
  • Peripheral neuropathy of ≥ Grade 2 by CTCAE (Japanese edition JCOG version 4.03)
  • Other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study (e.g. Patients who might agree to participate under compulsion).

Trial locations and contacts

155 sites in 1 country.

155 sites in 1 country

Japan155 sites

  • Study site

    Aizu-Wakamatsu, Fukushima

  • Study site

    Akashi, Hyōgo

  • Study site

    Akita

  • Study site

    Amagasaki, Hyōgo

  • Study site

    Aomori

  • Study site

    Bunkyo-ku, Tokyo

  • Study site

    Chiba

  • Study site

    Chiyoda-ku, Tokyo

  • Study site

    Chuo-ku, Tokyo

  • Study site

    Daisen, Akita

  • Study site

    Fujisawa, Kanagawa

  • Study site

    Fukui

  • Study site

    Fukuoka

  • Study site

    Fukuyama, Hiroshima

  • Study site

    Gifu

  • Study site

    Hakodate, Hokkaido

  • Study site

    Hakusan, Ishikawa-ken

  • Study site

    Hamamatsu, Shizuoka

  • Study site

    Hashima, Gifu

  • Study site

    Himeji, Hyōgo

  • Study site

    Hirakata, Osaka

  • Study site

    Hiratsuka, Kanagawa

  • Study site

    Hirosaki, Aomori

  • Study site

    Hitachi, Ibaraki

  • Study site

    Ibaraki

  • Study site

    Ichinomiya, Aichi-ken

  • Study site

    Ikoma, Nara

  • Study site

    Isehara, Kanagawa

  • Study site

    Ishinomaki, Miyagi

  • Study site

    Itabashi-ku, Tokyo

  • Study site

    Iwaki, Fukushima

  • Study site

    Iwakuni, Yamaguchi

  • Study site

    Izumi, Shimane

  • Study site

    Izumo, Shimane

  • Study site

    Izunokuni, Shizuoka

  • Study site

    Kaga, Ishikawa-ken

  • Study site

    Kagoshima

  • Study site

    Kahoku, Ishikawa-ken

  • Study site

    Kakamigahara, Gifu

  • Study site

    Kamakura, Kanagawa

  • Study site

    Kanazawa, Ishikawa-ken

  • Study site

    Kanazawachō, Kanagawa

  • Study site

    Kasama, Ibaraki

  • Study site

    Kashiwa, Chiba

  • Study site

    Kawachi-Nagano, Osaka

  • Study site

    Kawagoe, Saitama

  • Study site

    Kida, Kagawa-ken

  • Study site

    Kitaadachi, Saitama

  • Study site

    Kitakyushu, Fukuoka

  • Study site

    Kitami, Hokkaido

  • Study site

    Kobe, Hyōgo

  • Study site

    Kochi

  • Study site

    Kofu, Yamanashi

  • Study site

    Koga, Fukuoka

  • Study site

    Koga, Fukuoka

  • Study site

    Komaki, Aichi-ken

  • Study site

    Komatsushimachō, Tokushima

  • Study site

    Kōnan, Aichi-ken

  • Study site

    Kōriyama, Fukushima

  • Study site

    Koshigaya, Saitama

  • Study site

    Koto-ku, Tokyo

  • Study site

    Kumamoto

  • Study site

    Kurashiki, Okayama-ken

  • Study site

    Kurobe-shi, Toyama

  • Study site

    Kurume, Fukuoka

  • Study site

    Kushiro, Hokkaido

  • Study site

    Kyoto

  • Study site

    Machida, Tokyo

  • Study site

    Maebashi, Gunma

  • Study site

    Marugame, Kagawa-ken

  • Study site

    Matsumoto, Nagano

  • Study site

    Matsuyama, Ehime

  • Study site

    Matsuzaka, Mie-ken

  • Study site

    Meguro-ku, Tokyo

  • Study site

    Minato-ku, Tokyo

  • Study site

    Minokamo, Gifu

  • Study site

    Misawa, Aomori

  • Study site

    Miyazaki

  • Study site

    Moriguchi, Osaka

  • Study site

    Morioka, Iwate

  • Study site

    Moriyama, Shiga

  • Study site

    Murata, Miyagi

  • Study site

    Musashino, Tokyo

  • Study site

    Nagakute, Aichi-ken

  • Study site

    Nagano

  • Study site

    Nagasaki

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Naha, Okinawa

  • Study site

    Nanao, Ishikawa-ken

  • Study site

    Nankoku, Kochi

  • Study site

    Natori-shi, Miyagi

  • Study site

    Neyagawa, Osaka

  • Study site

    Niigata

  • Study site

    Nishinomiya, Hyōgo

  • Study site

    Obihiro, Hokkaido

  • Study site

    Ōgaki, Gifu

  • Study site

    Okayama

  • Study site

    Okazai, Gifu

  • Study site

    Okazaki, Aichi-ken

  • Study site

    Okinawa

  • Study site

    Ōmura, Nagasaki

  • Study site

    Omuta, Fukuoka

  • Study site

    Osaka

  • Study site

    Ōsaki, Miyagi

  • Study site

    Ōta, Gunma

  • Study site

    Ōta-ku, Tokyo

  • Study site

    Otaru, Hokkaido

  • Study site

    Ōtsu, Shiga

  • Study site

    Ryūgasaki, Ibaraki

  • Study site

    Saga

  • Study site

    Sagamihara, Kanagawa

  • Study site

    Saitama

  • Study site

    Sakata, Yamagata

  • Study site

    Saku, Nagano

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sasebo, Nagasaki

  • Study site

    Sayama, Osaka

  • Study site

    Sendai, Miyagi

  • Study site

    Shimotsuga, Tochigi

  • Study site

    Shimotsuke, Tochigi

  • Study site

    Shinagawa-ku, Tokyo

  • Study site

    Shinjuku-ku, Tokyo

  • Study site

    Shirakawa, Fukushima

  • Study site

    Shizuoka

  • Study site

    Suita, Osaka

  • Study site

    Sunto, Shizuoka

  • Study site

    Takamatsu, Kagawa-ken

  • Study site

    Takaoka, Toyama

  • Study site

    Tenri, Nara

  • Study site

    Tokushima

  • Study site

    Tomigusuku, Okinawa

  • Study site

    Tōon, Ehime

  • Study site

    Toyama

  • Study site

    Toyoake, Aichi-ken

  • Study site

    Toyohashi, Aichi-ken

  • Study site

    Toyokawa, Aichi-ken

  • Study site

    Toyota, Aichi-ken

  • Study site

    Tsu, Mie-ken

  • Study site

    Tsuchiura, Ibaraki

  • Study site

    Tsukuba, Ibaraki

  • Study site

    Tsuruga, Fukui

  • Study site

    Tsuruoka, Yamagata

  • Study site

    Ube, Yamaguchi

  • Study site

    Urasoe, Okinawa

  • Study site

    Utsunomiya, Tochigi

  • Study site

    Yachiyo, Chiba

  • Study site

    Yamagata

  • Study site

    Yamatotakada, Nara

  • Study site

    Yatomi, Aichi-ken

  • Study site

    Yokkaichi, Mie-ken

  • Study site

    Yokohama, Kanagawa

  • Study site

    Yokosuka, Kanagawa

  • Study site

    Yonago, Tottori

  • Study site

    Yoshida, Fukui

  • Study site

    Yufu, Oita Prefecture

Other trials in Japan

About this study

Official title: A Phase III, Randomized, Controlled Study of mFOLFOX6 + Bevacizumab Combination Therapy Versus mFOLFOX6 + Panitumumab Combination Therapy in Chemotherapy-naive Patients With KRAS/NRAS Wild-type, Incurable/Unresectable, Advanced/Recurrent Colorectal Cancer

The purpose of this study is to verify the efficacy of mFOLFOX6 + panitumumab combination therapy and mFOLFOX6 + bevacizumab combination therapy in first-line treatment of chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer.

Read the detailed description

The purpose of this study is to verify the efficacy of mFOLFOX6 + panitumumab combination therapy and mFOLFOX6 + bevacizumab combination therapy in first-line treatment of chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer.

This study will enroll a total of approximately 800 participants (400 per group).

Participants will be randomized to either the mFOLFOX6 + panitumumab arm (Group P) or mFOLFOX6 + bevacizumab arm (Group B) at 1:1 ratio at the time of registration.

Group P and Group B treatment regimen shown below should be administered once every two weeks, following dose, schedule and route of administration.

Group P; mFOLFOX6 + panitumumab combination therapy, once every two weeks OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg

Group B; mFOLFOX6 + bevacizumab combination therapy, once every two weeks OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg

This trial is conducted by multicenter and is scheduled for 12 months as whole administration period.

Being tested
oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab, oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab
Keywords
Metastatic colorectal cancer, Panitumumab, mFOLFOX6, Bevacizumab
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumabDrug

    oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion

  • oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumabDrug

    oxaliplatin (OXA), levofolinate calcium (l-LV), bevacizumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion

Study groups in NCT02394795
Study groupRoleWhat they receive
Group P; mFOLFOX6 + panitumumab combination therapyExperimentalOXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks.
Receives: Drug: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab
Group B; mFOLFOX6 + bevacizumab combination therapyActive comparatorOXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks.
Receives: Drug: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab

What is being measured

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

  1. OS in Participants With Left-sided Tumors

    OS was measured as the time from the date of randomization to the date of death due to any cause. The left-sided tumors were defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum.

    Measured: Up to approximately 60 months

  2. Overall Survival (OS) in All Participants

    OS was measured as the time from the date of randomization to the date of death due to any cause.

    Measured: Up to approximately 60 months

Secondary outcomes (6)

  1. Progression-Free Survival (PFS) in Participants With Left-sided Tumors

    PFS was defined as the time from the date of randomization to the earlier of Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death due to any cause. The left-sided tumors were defined as primary tumors occupying a left-sided site include the descending colon, sigmoid colon, and rectum.

    Measured: Up to approximately 60 months

  2. Progression-Free Survival (PFS) in All Participants

    PFS was defined as the time from the date of randomization to the earlier of Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death due to any cause.

    Measured: Up to approximately 60 months

  3. Response Rate (RR) in All Participants

    RR was defined as number of participants who achieve Complete Response (CR) and Partial Response (PR) as the best overall response per RECIST version 1.1.The best overall response was CR, followed by PR, stable disease (SD), progressive disease (PD), and not evaluable (NE). CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters as the best overall response after randomization., SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

    Measured: Up to approximately 60 months

  4. Duration of Response (DOR)

    DOR means that the period from the day when either CR or PR is first confirmed until the day of documented PD or the day of death due to all causes, whichever occurs earlier.

    Measured: Up to approximately 60 months

  5. Number of Participants Treated With Curative Surgical Resection After Chemotherapy

    Curative surgical resection was defined as complete resection.

    Measured: Up to approximately 60 months

  6. Number of Participants With Treatment-emergent Adverse Events (TEAE)

    Adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurred in the treatment period after receiving the protocol treatment.

    Measured: Up to approximately 60 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 2015 (estimated)
  2. Study start29 May 2015
  3. Primary completion14 Jan 2022
  4. Study completion14 Jan 2022

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
823 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02394795
Sponsor's protocol ID
Panitumumab-3001
Other IDs
U1111-1164-9167, JapicCTI-142731, jRCTs031180246, UMIN000016776
Acronym
PARADIGM
Status last verified
Jan 2023
First submitted
16 Mar 2015
Last updated
1 Nov 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

  • Shitara K, Muro K, Watanabe J, Yamazaki K, Ohori H, Shiozawa M, Takashima A, Yokota M, Makiyama A, Akazawa N, Ojima H, Yuasa Y, Miwa K, Yasui H, Oki E, Sato T, Naitoh T, Komatsu Y, Kato T, Mori I, Yamanaka K, Hihara M, Soeda J, Misumi T, Yamamoto K, Yamashita R, Akagi K, Ochiai A, Uetake H, Tsuchihara K, Yoshino T. Baseline ctDNA gene alterations as a biomarker of survival after panitumumab and chemotherapy in metastatic colorectal cancer. Nat Med. 2024 Mar;30(3):730-739. doi: 10.1038/s41591-023-02791-w. Epub 2024 Feb 12.

    PubMed 38347302

  • Watanabe J, Muro K, Shitara K, Yamazaki K, Shiozawa M, Ohori H, Takashima A, Yokota M, Makiyama A, Akazawa N, Ojima H, Yuasa Y, Miwa K, Yasui H, Oki E, Sato T, Naitoh T, Komatsu Y, Kato T, Hihara M, Soeda J, Misumi T, Yamamoto K, Akagi K, Ochiai A, Uetake H, Tsuchihara K, Yoshino T. Panitumumab vs Bevacizumab Added to Standard First-line Chemotherapy and Overall Survival Among Patients With RAS Wild-type, Left-Sided Metastatic Colorectal Cancer: A Randomized Clinical Trial. JAMA. 2023 Apr 18;329(15):1271-1282. doi: 10.1001/jama.2023.4428.

    PubMed 37071094

  • Yoshino T, Uetake H, Tsuchihara K, Shitara K, Yamazaki K, Oki E, Sato T, Naitoh T, Komatsu Y, Kato T, Yamanaka K, Iwasaki K, Soeda J, Hihara M, Yamanaka T, Ochiai A, Muro K. Rationale for and Design of the PARADIGM Study: Randomized Phase III Study of mFOLFOX6 Plus Bevacizumab or Panitumumab in Chemotherapy-naive Patients With RAS (KRAS/NRAS) Wild-type, Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2017 Jun;16(2):158-163. doi: 10.1016/j.clcc.2017.01.001. Epub 2017 Jan 24.

    PubMed 28237539

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab and oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab in people with Colorectal Cancer, run by Takeda at 155 sites in Japan.

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 25 inclusion and 22 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: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 155 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 1 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

OS in Participants With Left-sided Tumors (time frame: Up to approximately 60 months). 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 NCT02394795, which also lists 3 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 1 Nov 2023.

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PARADIGM Clinical Trial NCT02394795 | AzTrials